Ato-oxy + Oxygen for Sleep Apnea in Down Syndrome

(EDIT OSA Trial)

Not yet recruiting at 3 trial locations

Overseen By Natalie Provencio-Dean

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Arizona

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

Down syndrome is the most common genetic cause of intellectual disability. People with Down syndrome often have obstructive sleep apnea (OSA), a condition where people have difficulties with breathing while asleep. OSA can lead to poor sleep, worse quality of life, behavior problems and more difficulties with thinking ("cognitive impairment"). Current treatments for OSA in people with Down syndrome are not very effective or require surgery. The combination of 2 medications, atomoxetine and oxybutynin ("ato-oxy") is a promising treatment for OSA in people with Down syndrome, but ato-oxy does not work for everyone with Down syndrome. Similarly, oxygen is effective for OSA in some people, but does not work for everyone. This study will evaluate the use a precision medicine approach to increase the effectiveness of OSA treatment in people with Down syndrome. The study will compare two groups. In the first group, everyone will be treated with ato-oxy. In the second group, a precision medicine approach will be used to assign participants to either ato-oxy or oxygen therapy, based on the specific reasons they have OSA.

The research team will enroll 200 children (age 6-17 years old) and adults with Down syndrome and OSA from five sites across the country. Half of participants will randomly receive ato-oxy while the other will receive either oxygen or ato-oxy dependent upon which treatment would be expected to work better for them. The research team will measure OSA severity, quality of life, behavior and cognition at the start of the study and after 12 months of treatment for every participant. The study will also track any treatment side effects for each treatment group.

Who Is on the Research Team?

Daniel Combs, MD

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

This trial is for children and adults aged 6-17 with Down syndrome and obstructive sleep apnea (OSA). Participants must have a confirmed diagnosis of both conditions. The study excludes individuals who do not meet the age requirement or have other health issues that could interfere with the treatment or data collection.

Inclusion Criteria

I am 6 years old or older.

My gender or ethnicity does not limit my participation.

I have been diagnosed with Down syndrome.

Exclusion Criteria

I am currently taking MAO inhibitors.

I have difficulty emptying my bladder completely.

Significant traumatic brain injury

What Are the Treatments Tested in This Trial?

Interventions

• Endotype Directed Treatment

Trial Overview The study tests two treatments for OSA in people with Down syndrome: atomoxetine combined with oxybutynin ('ato-oxy') versus oxygen therapy. It uses precision medicine to determine which treatment might work best based on individual OSA causes, comparing effectiveness over a year.

How Is the Trial Designed?

Group I: Endotype Directed Treatment Experimental Treatment 2 Interventions

Participants receive either atomoxetine and oxybutynin (ato-oxy) or oxygen nightly. Participants receive the treatment expected to be most beneficial to them based on their baseline sleep study and OSA characteristics (OSA endotype).

Group II: Uniform therapy (ato-oxy) Active Control 1 Intervention

All participants receive the combination of atomoxetine and oxybutynin (ato-oxy) once nightly

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+